RecruitingNot ApplicableNCT05448365

Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid


Sponsor

Lo.Li.Pharma s.r.l

Enrollment

60 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product.


Eligibility

Sex: FEMALEMin Age: 30 YearsMax Age: 40 Years

Inclusion Criteria3

  • uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
  • eligible for surgery
  • symptoms like menometrorrhagia or pelvic pain

Exclusion Criteria5

  • BMI\>30
  • currently pregnant or breastfeeding
  • diabetic
  • suspect of malignancy
  • diagnosis of cancer

Interventions

DIETARY_SUPPLEMENTEpigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol

The patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25μg Vitamin D

DIETARY_SUPPLEMENTPlacebo

Maltodextrines


Locations(2)

Ospedale Dario camberlingo

Francavilla Fontana, Apulia, Italy

Ospedale Veris Delli Ponti

Scorrano, Apulia, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05448365


Related Trials